US Supreme Court rules that six months' notice of commercial marketing can be given prior to FDA approval in Sandoz vs. Amgen

Justices also provided much needed clarity on the patent litigation process, often referred to as the ‘patent dance’

As the first company to gain approval for and launch a biosimilar under the BPCIA's new regulatory pathway, Sandoz continues to pioneer the path forward for these high-quality, cost-effective medicines in the US

Holzkirchen, 13 June 2017 – Sandoz, a Novartis division, today announced that the Supreme Court of the United States ruled unanimously in favor of Sandoz on the two key legal issues before the Court in Sandoz v. Amgen. First, the ruling confirms that biosimilar companies do not need to wait for US Food and Drug Administration (FDA) approval in order to provide 180 days’ notice to reference product manufacturers of their intention to launch a product. This ruling could speed patient access to important, potentially life-saving medications and help to reduce rising healthcare costs, sooner. Second, the Justices provided additional clarity on how the “patent dance,” which is the process by which biosimilar manufacturers may provide confidential and proprietary information to reference product manufacturers in the patent exchange process, will work. The Supreme Court confirmed Sandoz’ position that there is no federal remedy to force a biosimilar applicant to engage in the patent dance – the sponsor’s remedy under the federal statutory scheme designed by Congress is to sue the biosimilar applicant for patent infringement. However, the Court remanded some questions regarding how state law claims could relate to the patent dance to the Federal Circuit for further consideration.

“Biosimilars offer significant value to patients, providers and payers, increasing the number of treatment options available to patients across many disease areas at a reduced cost to the healthcare system. The Justices’ unanimous ruling on the notice of commercial marketing will help expedite patient access to life-enhancing treatments. We also appreciate the clarity provided on the patent dance, which will help the biosimilars industry move forward,” said Carol Lynch, Global Head of Biopharmaceuticals, Sandoz. “As the global leader in biosimilars, it is our responsibility to help eliminate barriers so patients can access more affordable medicine. The results of this Supreme Court case reinforce that the work we are doing every day has meaning to the patients and customers we are here to help.”

Sandoz v. Amgen was brought before the Supreme Court after the Federal Circuit Court of Appeals decided that biosimilar manufacturers must wait until six months after FDA approval to begin selling their biosimilar medicines due to the operation of the notice of commercial marketing provision of the statute. That Court further held that the patent dance is not required. The Federal Circuit’s decision regarding the notice of commercial marketing effectively created 12 and a half years of market exclusivity for reference product manufacturers versus the 12 years Sandoz believes Congress intended. Sandoz disagreed with the notice of commercial marketing ruling and petitioned the Supreme Court to take up the case. Amgen disagreed with the ”patent dance” ruling and also sought clarification from the nation’s highest court. In December 2016, the US Solicitor General recommended that the Supreme Court hear the case and supported Sandoz positions on both issues.

Sandoz is responsible for the first biosimilars to be applied for, approved and launched in the US (under the BPCIA's new regulatory pathway in the US), EU and Japan, among other countries, and is currently the only company with two US-approved biosimilars – one in oncology supportive care and one in immunology. The company is the pioneer in biosimilars and was uniquely situated to argue this case that will have a marked impact on the future of the industry.

America spent $323 billion in 2016 on prescription medicines1, and biologics are estimated to account for 28% of drug spending by 20202. One analysis predicted that biosimilars could deliver up to $44 billion in savings to the US healthcare system by 2024 while driving healthy competition and innovation3. Pharmacy benefits manager Express Scripts estimates that the US likely wasted more than $45 million for every month that the Sandoz biosimilar Zarxio® (filgrastim-sndz) was delayed from coming to market as a result of the notice of commercial marketing issue argued in Sandoz v. Amgen4; because of today’s Supreme Court’s decision, this healthcare savings could be realized for future biosimilars.

Sandoz is committed to increasing patient access to high-quality, life-enhancing biosimilars. It is the pioneer and global leader in biosimilars, and currently markets three biosimilars worldwide. Sandoz has a leading biosimilar pipeline and plans to launch five biosimilars of major oncology and immunology biologics across key geographies by 2020. As a division of the Novartis Group, Sandoz is well-positioned to lead the biosimilars industry based on its experience and capabilities in development, manufacturing and commercialization.

DisclaimerThe foregoing release contains forward-looking statements that can be identified by words such as “potentially,” “can,” “launch,” “continues,” “path forward,” “intention,” “could,” “may,” “will,” “claims,” “move forward,” “likely,” “could,” “committed,” “pipeline,” “plans,” “by 2020,” “well-positioned,” or similar terms, or by express or implied discussions regarding potential marketing approvals for biosimilars in the Sandoz biosimilar pipeline, or regarding potential future revenues from Zarxio, the other marketed products in the Sandoz biosimilar portfolio, and the potential products in the Sandoz biosimilar pipeline. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that any potential products in the Sandoz biosimilar pipeline will be submitted or approved for sale in any market, or for any or all of the indications in the reference product’s label, or at any particular time. Neither can there be any guarantee that Zarxio or any other marketed products in the Sandoz biosimilar portfolio will be submitted or approved for sale in any additional markets, or for any or all of the indications in the reference product’s label, or at any particular time. Nor can there be any guarantee that Zarxio, the other marketed products in the Sandoz biosimilar portfolio, and the potential products in the Sandoz biosimilar pipeline will be commercially successful in the future. In particular, management’s expectations regarding Zarxio and such other biosimilar candidates and marketed products could be affected by, among other things, regulatory actions or delays or government regulation generally; the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; competition in general, including potential approval of additional versions of a biosimilar product or pipeline project; global trends toward health care cost containment, including government, industry and general public pricing and reimbursement pressures; litigation outcomes, including intellectual property disputes or other legal efforts to prevent or limit Sandoz from selling its biosimilar products; the particular prescribing preferences of physicians and patients; general economic and industry conditions; safety, quality or manufacturing issues, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Sandoz Sandoz is a global leader in generic pharmaceuticals and biosimilars. As a division of the worldwide Novartis Group, our purpose is to discover new ways to improve and extend people’s lives. We contribute to society’s ability to support growing healthcare needs by pioneering novel approaches to help people around the world access high-quality medicine. Our portfolio of approximately 1000 molecules, covering all major therapeutic areas, accounted for 2016 sales of USD 10.1 billion. In 2016, our products reached well over 500 million patients and we aspire to reach one billion. Sandoz is headquartered in Holzkirchen, in Germany’s Greater Munich area.

References

Medicines Use and Spending in the U.S.: A Review of 2016 and Outlook to 2021. Quintiles IMS Institute. May 2017.

Delivering on the Potential of Biosimilar Medicines: The Role of Functioning Competitive Markets. IMS Institute. March 2016.